Topic 1: Introduction to Evidence Generation
Completion requirements
Evidence generation is the process of collecting and analyzing data to demonstrate the safety, performance, and clinical benefit of a medical technology.
It plays a critical role in regulatory approval, clinical adoption, and post-market evaluation.
| Aspect | Description |
|---|---|
| Purpose | Demonstrate safety and effectiveness |
| Data sources | Clinical trials, registries, real-world data |
| Key outcomes | Diagnostic accuracy, patient benefit, usability |
| Stakeholders | Researchers, clinicians, manufacturers, regulators |
Last modified: Thursday, 30 October 2025, 9:03 PM